D.med Technologies: From concept idea to a secure medical product in the market

• Streamlined process: Consolidate your development journey with a single, experienced partner. Eliminate the need to manage multiple vendors, ensuring seamless communication and efficient project execution.
• Reduced costs: Benefit from our expertise in optimizing device profitability. We identify cost-saving opportunities throughout the development process without compromising quality.
• Faster time to market: Our integrated approach eliminates delays and bottlenecks associated with managing multiple vendors. We work efficiently to expedite your product launch.
• Improved quality and security: Maintain the highest quality standards throughout development with our rigorous processes and in-house expertise. We ensure your device adheres to all regulatory requirements and cybersecurity protocols.

Our comprehensive range of services enables you to overcome any development hurdle:

1. Device Profitability:

• Economical assessments & feasibility studies
• Cost reduction by design
• Profitability increase, managed end-to-end

2. Regulatory Affairs and QM:

• Market Access Strategies (EU & ROW)
• Support in Transition MDD - MDR
• Regulatory Radar for new/changed requirements
• Post Market Surveillance

3. Cybersecurity:

• Pre-market Cybersecurity Activities (MDR and FDA Compliance)
• Cybersecurity Risk Management
• Penetration Testing
• Post-market Surveillance

4. Medical Software:

• Software Development for Medical Devices
• Cloud-Based Healthcare Solutions
• Source Code Development
• Software Testing
• Static Code Analysis
• Hazard Analysis
• Embedded System/Component Development

5. Clinical Affairs and Research:

• Guidance from experienced healthcare professionals during development
• Creation of Clinical Evaluation Plan and Clinical Evaluation Report in accordance with MDR and MEDDEV 2.7/1 Rev. 4
• Clinical Investigation in accordance with MDR, MEDDEV, ISO 14155 2020-07
• Clinical studies to evaluate results in own in-house laboratory
• Collection of clinical data for medical device development/ registration and AI applications

6. Development of complex mechanical systems:

• Pre-development, Development & Improvement of Application Systems
• Complex mechanical systems
• Testing & Prototyping
• Development of test methods and testing devices
• High precise Test equipment production (tests stands/test benches)
• Measurement equipment/production

Join Us at MedtecLIVE 2024! Hall 1 / 1-543

Let's discuss how we can simplify your journey and accelerate your success in bringing your innovative medical device to market.

We look forward to partnering with you!